MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NOGA XP CARDIAC NAVIGATION SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number UNK_NOGA XP

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Tachycardia (2095)

Event Date 12/21/2019

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: mathiasen ab, qayyum aa, jørgensen e, helqvist s, kofoed kf, haack-sørensen m, ekblond a, kastrup j.Bone marrow-derived mesenchymal stromal cell treatment in patients with ischaemic heart failure: final 4-year follow-up of the msc-hf trial.Eur j heart fail.2020 may;22(5):884-892.Doi: 10.1002/ejhf.1700.Epub 2019 dec 21.Pmid: 31863561.Objective/methods/study data: the mesenchymal stromal cells- heart failure trial was a phase ii, single-center, randomized, double-blind, placebo-controlled study.The study assessed 4-year outcomes of intramyocardial injections of autologous bone marrow-derived mesenchymal stromal cells in 60 patients with ischemic heart failure, new york heart association class ii¿iii, left ventricular ejection fraction <45% and no further treatment options were treated between april 2009 and september 2008.Patients were randomized 2:1 to intramyocardial injections of mesenchymal stromal cells or placebo.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: noga-xp.Concomitant other biosense webster devices that were also used in this study: myostar injection catheters.Concomitant non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: there were two serious adverse events in relation to the noga procedure: one patient with a history of ventricular tachycardia developed ventricular tachycardia during the noga mapping procedure.The patient reverted to sinus rhythm by his implantable cardioverter-defibrillator unit and the procedure was canceled.One patient experienced double-vision and dizziness during the injection procedure.Cerebral ct afterward was normal, but the incident was diagnosed as a minor stroke by the neurologist.The patient was without sequelae and completed the follow-up.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: mathiasen ab, qayyum aa, jørgensen e, helqvist s, kofoed kf, haack-sørensen m, ekblond a, kastrup j.Bone marrow-derived mesenchymal stromal cell treatment in patients with ischaemic heart failure: final 4-year follow-up of the msc-hf trial.Eur j heart fail.2020 may;22(5):884-892.Doi: 10.1002/ejhf.1700.Epub 2019 dec 21.Pmid: 31863561.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).

• Brand Name: NOGA XP CARDIAC NAVIGATION SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14409561
• MDR Text Key: 291741185
• Report Number: 2029046-2022-01029
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NOGA XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening